A Multicenter Belgian Trial of Ventral Hernia Repair (UNITE)

NCT04437043 | Active Not Recruiting DMC

• 1 other identifier: BC-06967
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with incisional midline ventral hernias with a minimal width of 3 cm and a maximal width of 8 cm, treated according to the standard practice of the participating investigators. Patients can be treated with the following ventral hernia repair approaches:

• Laparoscopic ventral hernia repair with closure of the defect (IPOM+)
• Open ventral hernia repair with closure of the defect (retromuscular repair)
• Robotic ventral hernia repair with closure of the defect (retromuscular repair) To evaluate the total number of days spent in the hospital within a period of 90 days post-operative. This will be calculated by adding the hospital length of stay for initial surgery or index-procedure, length of stay for any additional readmission resulting from the surgery or re-interventions, and emergency room visits resulting from the surgery or Serious Adverse Event (SAE) related to the index-procedure. Secondary objectives: To assess the safety, performance and efficacy of laparoscopic, open and robotic ventral hernia repair.

Conditions

Ventral Hernia

Keywords

ventral hernia

Outcome Measures

Primary Outcomes (1)

• Total number of days in the hospital

  This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery. This information will be collected up to 90 days after the surgery. The hospital length of stay for the initial surgery will be assessed using a Modified Post Anaesthetic Discharge Scoring System (PADSS)

  90 days post-operative

Secondary Outcomes (11)

• Intra-operative adverse events

  index procedure, 30 days post-operative, and 90 days post-operative

• Number of participants with Surgical Site Infection (SSI)

  post-operative at 30 days, 1 year, and 2 years

• Number of participants with Surgical Site Occurence (SSO)

  post-operative at 30 days, 1 year, and 2 years

• Operating time

  index procedure

• Effective day of discharge

  index procedure, and post-operative at 30 days

Study Arms (3)

Laparoscopic ventral hernia repair with closure of the defect

OTHER

In laparoscopic intraperitoneal onlay mesh or IPOM repair, the mesh is inserted intra-abdominally and fixed to the peritoneum / abdominal wall. The general steps include safe entry into the peritoneum, insufflation and placement of the trocars to gain access and visibility (via laparoscope) of the defect. Careful adhesiolysis is performed, which is the removal of scar tissue connecting tissues and organs. The content of the hernia, which may include intestine and fatty tissue, is returned into the abdominal cavity. After closure of the hernia defect, a wide intraperitoneal mesh is fixed over the defect. Desufflation releases the gas from the abdomen. The trocars will be removed and the incisions are closed.

Other: quality of life questionnaires

Open ventral hernia repair with closure of the defect

OTHER

An open retromuscular ventral hernia repair involves an incision through the abdominal wall. Adhesiolysis is performed and the content of the hernia is returned into the abdominal cavity. The posterior rectus sheath is separated from the rectus muscle and closed, which closes the abdominal cavity. The mesh is then placed behind the muscle and anterior to the re-approximated posterior rectus sheath. Preperitoneal mesh extension is allowed via transversus abdominis release (TAR). The anterior rectus sheath is closed over the mesh, which closes the hernia.

Other: quality of life questionnaires

Robotic ventral hernia repair with closure of the defect

OTHER

A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar closure of the hernia defect and similar retromuscular mesh placement as for the open approach. Preperitoneal mesh extension is allowed via TAR. The da Vinci System is a robotic-assisted surgical device that allows the surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of the abdominal cavity. Rather than one long incision with open repair, four to six small incisions are made along the outer part of the abdomen between the rib cage and the hip.

Other: quality of life questionnaires

Interventions

quality of life questionnaires OTHER

pain will be recorded in rest and activity (VAS) and patients will complete the quality of life questionnaires (CCS, BIQ). Also, the intake of analgesic medication will be registered. A clinical examination is conducted to evaluate the occurrence of seroma and to evaluate recurrence, defined as a protrusion of the contents of the abdominal cavity or preperitoneal fat through the defect, which is no longer covered by the mesh.

Laparoscopic ventral hernia repair with closure of the defect; Open ventral hernia repair with closure of the defect; Robotic ventral hernia repair with closure of the defect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with incisional midline ventral hernia (M2: epigastric, M3: umbilical, M4: infra-umbilical) with a minimal width of 3 cm and a maximum width of 8 cm. Multiple hernia defects (Swiss cheese) are allowed according to European Hernia Society (EHS) classification (Appendix 1).
• Recurrences are only allowed to be included after former primary repair (suture repair without mesh).
• Patients with ASA grade I to III.
• Patient is at least 18 years old.
• Patient must sign and date the informed consent form prior to treatment.
• Patient is able to tolerate general anesthesia.

You may not qualify if:

• Patient with a life expectancy of less than 2 years.
• Patient is suspected of being unable to comply with the study protocol.
• Patient is pregnant.
• Patient needs acute surgery.
• Patient is enrolled in another study.

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Royal Belgian Society for Surgery: collaborator
• Archer Research: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, East Flanders, 9000, Belgium

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Investigator-initiated, academic, prospective, interventional, multicenter study

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: June 18, 2020
• Study Start: December 16, 2020
• Primary Completion: July 31, 2023
• Study Completion: December 30, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)